FDA approves Lonsurf (trifluridine and tipiracil) to treat advanced colorectal cancer- Taiho + Servier
The FDA has approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) from Taiho for patients with an advanced form of colorectal cancer who are no longer responding to other therapies. Lonsurf is an oral medication intended to treat patients with advanced (metastatic) colorectal cancer who have been previously treated with chemotherapy and biological therapy.
The efficacy and safety of Lonsurf were evaluated in an international, randomized, double-blind study involving 800 patients with previously treated metastatic colorectal cancer. Study participants received Lonsurf plus best supportive care, or placebo plus best supportive care until their disease worsened or side effects became intolerable. The primary endpoint of the study was overall survival and the secondary endpoint was progression-free survival. Patients treated with Lonsurf lived an average of 7.1 months compared to 5.3 months for those treated with placebo. On average, the time to disease progression was 2 months for patients on Lonsurf compared to 1.7 months for patients receiving placebo.
Comment: European rights to Lonsurf are licensed to Servier Laboratories.
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